Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies (English)
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In:
Therapeutic Innovation & Regulatory Science
;
54
, 6
; 1489-1500
;
2020
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies
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Contributors:Elmer, Mary ( author ) / Florek, Cathy ( author ) / Gabryelski, Lori ( author ) / Greene, Alison ( author ) / Inglis, Anne Marie ( author ) / Johnson, Karen L. ( author ) / Keiper, Tanja ( author ) / Ludlam, Sean ( author ) / Sharpe, T. J. ( author ) / Shay, Kathyjo ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 54, 6 ; 1489-1500
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Publisher:
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- New search for: Springer Nature
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Place of publication:[New York]
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Publication date:2020
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ISSN:
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ZDBID:
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DOI:
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Type of media:Article (Journal)
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Type of material:Electronic Resource
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Language:English
- New search for: 44.38 / 44.38
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Source:
Table of contents – Volume 54, Issue 6
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 1259
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Medical Information Practices Across the Pharma Industry: What Can We Learn from Benchmarking Surveys?Shah, Ina / Janajreh, Izzat / Fung, Stacey M. et al. | 2020
- 1263
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phactMI Benchmarking Survey on Content Development and Inquiry ManagementByun, Jacqueline / Jong, Jin Ah / Gangat, Amina / Flowers, Teresa / Gazo, Andrew / Shah, Ina et al. | 2020
- 1269
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Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Results of Organizational Structure and Resourcing of Medical Information Services in Support of Building Departmental StrategiesMarasigan, Kirstie / Doshi, Sara / Fung, Stacey et al. | 2020
- 1275
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Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Trends, Drivers, and Value of Product Support Activities, Key Performance Indicators, and Other Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information DepartmentsPatel, Meera / Jindia, Leena / Fung, Stacey / Kadowaki, Richard / Marasigan, Kirstie et al. | 2020
- 1282
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Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member CompaniesPatel, Priya / Gaspo, Rania / Crisan, Annamaria / Lee, Jung et al. | 2020
- 1291
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phactMI™ Benchmarking Survey: Analysis of 27 Medical Information Departments Responses to Inquiries from Health Care Decision MakersD’Ascoli, AnnaMaria / Gazo, Andrew / Yueh, Sue / Egri, Florence / Akanda, Shemanta et al. | 2020
- 1296
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Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research PurposesRitchey, Mary E. / Girman, Cynthia J. et al. | 2020
- 1303
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Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMIHermes-DeSantis, Evelyn R. / Johnson, Renee M. / Redlich, Alysa / Patel, Bindi / Flanigan-Minnick, Anne / Wnorowski, Susan / Cortes, Mabel M. / Han, Chang Woo / Vine, Elissa / Sarwar, Hamza et al. | 2020
- 1312
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Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm BirthSheehan, Sarah / Baer, Gerri / Romine, Morgan / Hudson, Lynn / Lim, Robert / Papadopoulos, Elektra / Campbell, Michelle / Daniel, Gregory / McCune, Susan et al. | 2020
- 1319
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Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration InitiativeSithole, Tariro / Mahlangu, Gugu / Salek, Sam / Walker, Stuart et al. | 2020
- 1330
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Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical TrialsGetz, Kenneth / Smith, Zachary / Shafner, Laura / Hanina, Adam et al. | 2020
- 1339
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A Systematic Review of the Efficacy and Safety of Aspirin When Delivered at Different Medication Times for the Primary and Secondary Prevention of Cardiovascular and Cerebrovascular DiseasesZhou, Boya / Wang, Qiaoyu / Zhao, Zhigang / Feng, Xin et al. | 2020
- 1349
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Benchmarking the Vendor Qualification ProcessGetz, Kenneth / Wilkinson, Michael / Turpen, Jay / Salotti, Dennis / Rye, Karen / Carnan, Elspeth / Profit, Deborah et al. | 2020
- 1359
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Coronavirus Disease 2019 (COVID-19) Spread and Pharmacovigilance Implications: Expert OpinionYamoah, Peter / Alalbila, Thelma Mpoku / Bangalee, Varsha / Oosthuizen, Frasia et al. | 2020
- 1363
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Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic EvaluationGuinn, Daphne / Madabushi, Rajanikanth / Wang, Yow-Ming / Brodsky, Eric / Zineh, Issam / Maxfield, Kimberly et al. | 2020
- 1372
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Factors that have an Impact on Abbreviated New Drug Application (ANDA) SubmissionsWittayanukorn, Saranrat / Rosenberg, Matthew / Schick, Andreas / Hu, Meng / Wang, Zhong / Babiskin, Andrew / Lionberger, Robert / Zhao, Liang et al. | 2020
- 1382
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Healthcare Professionals’ Perceptions of Infographics Within Medical Information Response LettersPatel, Zil / Patel, Chandni / Oreper, Jane / Patel, Hemali / Sajedeen, Autri et al. | 2020
- 1388
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Opinions and Trends of Healthcare Providers Concerning Scientific/Standard Response DocumentsYoung, James / Bhavsar, Roma / Byun, Jacqueline / Toscani, Michael / Reilly, Patrick / Hermes-DeSantis, Evelyn et al. | 2020
- 1398
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eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA GatewayHathaway, Joanne / Hom, Kevin / Reznichenko, Boris / Vaddempudi, Kousalya / D’Alonzo, Albert et al. | 2020
- 1404
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Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its DocumentationBujar, Magdalena / McAuslane, Neil / Connelly, Patricia / Walker, Stuart R. et al. | 2020
- 1416
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An Empirical Comparison of Statistical Methods for Missing Data in Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trials for Chronic Pain and Lipid-Lowering ProductsGnang, Jeanine / Kim, Yoonhee / Ren, Yi / Travis, James / Kim, Yongman et al. | 2020
- 1428
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A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016Patel, Prisha / Cerqueira, Daniela Marreco / Santos, Gustavo Mendes Lima / de Lima Soares, Renata / Sousa, Varley Dias / Liberti, Lawrence / McAuslane, Neil et al. | 2020
- 1436
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Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical ReviewSeifu, Yodit / Gamalo-Siebers, Margaret / Barthel, Friederike M.-S. / Lin, Junjing / Qiu, Junshan / Cooner, Freda / Ruan, Shiling / Walley, Rosalind et al. | 2020
- 1444
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Likelihood Ratio Test Method for Multiple Medical Devices Comparison Using Multiple-Site Data with Continuous OutcomesHu, Tingting / Xu, Jianjin / Huang, Lan / Xu, Zhiheng / Yao, Zhihao / Tiwari, Ram et al. | 2020
- 1453
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The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical TestingDiMasi, Joseph A. / Wilkinson, Michael et al. | 2020
- 1461
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The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech RepublicHoravova, L. / Nebeska, K. / Souckova, L. / Demlova, R. / Babula, P. et al. | 2020
- 1473
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Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of DrugsHarrison, Nicholas R. / Sager, Philip T. / Krucoff, Mitchell W. / Weber, Michael A. / White, William B. et al. | 2020
- 1477
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Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank MeetingLentz, Trevor A. / Curtis, Lesley H. / Rockhold, Frank W. / Martin, David / Andersson, Tomas L. G. / Arias, Carolyn / Berlin, Jesse A. / Binns, Cherie / Cook, Andrea / Cziraky, Mark et al. | 2020
- 1489
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Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical StudiesElmer, Mary / Florek, Cathy / Gabryelski, Lori / Greene, Alison / Inglis, Anne Marie / Johnson, Karen L. / Keiper, Tanja / Ludlam, Sean / Sharpe, T. J. / Shay, Kathyjo et al. | 2020
- 1501
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Characteristics of Drug Intervention Clinical Trials and Scientific Impact of the Trial Outcome: A Bibliometric Analysis Using the Relative Citation Ratio in Non-small Cell Lung Cancer from 2007 to 2016Noguchi, Yutaka / Kaneko, Masayuki / Narukawa, Mamoru et al. | 2020
- 1512
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AdEPro: Animation of Adverse Event Profiles—Presentation of an Easy-to-Use App for Visually Exploring Individual Study DataMentenich, Nicole / Tasto, Christoph / Becker, Bastian et al. | 2020
- 1522
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Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)Greene, Alison / Elmer, Mary / Ludlam, Sean / Shay, Kathyjo / Bentley, Sarah / Trennery, Claire / Grimes, Rebecca / Gater, Adam et al. | 2020
- 1534
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Characteristics on Drug Safety Measures in Japan Stratified by System Organ Classes and Therapeutic Categories in Relation to the Approval DateHiramatsu, Ayaka / Hanaoka, Hideki / Uyama, Yoshiaki et al. | 2020
- 1541
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Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017Getz, Kenneth A. / Smith, Zachary P. / Peña, Yaritza et al. | 2020
- 1551
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Statistical Evaluation of Clinical Trials Under COVID-19 PandemicChow, Shein-Chung / Zhang, Wei et al. | 2020
- 1557
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Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial DataGoren, Emily / Lin, Li-An / Blaustein, Robert O. / Ball, Greg et al. | 2020
- 1566
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Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene TherapiesLasiter, Laura / Campbell, Alicyn / Basch, Ethan / Hudgens, Stacie / Stewart, Mark / Wu, James J. / Leahy, Allison Barz / Allen, Jeff et al. | 2020